Richard di Natale, leader of the Australian Greens, recently accused the federal government of “ignoring the will of parliament” on importing medical marijuana, as physicians complain that the system’s multiple obstacles are preventing terminally ill patients from accessing their medicine. He plans to introduce a bill on Tuesday that will make it easier for importers to stock medical cannabis products.
Although the government legalized medical marijuana in 2016, medical practitioners are still unable to prescribe marijuana to terminally ill patients without prior authorization from a special access scheme under Category A of the Therapeutic Goods Administration, despite products themselves having approval. Even after legalization, patients still struggle to get their hands on it.
The law only permits access through Category B, which requires an approval letter from the Therapeutic Goods Administration, a doctor’s prescription, and approval from the territory or state government where patients reside. The process is impractical, long and complex, often taking several months, and frequently not fast enough to provide any help to terminally and severely ill patients.
Back in June, the Greens moved a motion in the Senate to provide terminally ill patients with faster access to medical cannabis by disallowing its removal from Category A. It passed with a 30-40 majority vote with support from Independent, Labor, and One Nation senators Lucy Gichuhi, David Leyonhjelm, Derryn Hinch, and Jacqui Lambie.
However, the response of the federal government’s Office of Drug Control was to write to importers warning that they would be in “breach of your permit and license conditions if you supply any imported medicinal cannabis product to a patient under Special Access Scheme A.” Di Natale, a practiced medical physician, said that the government is defying the Senate’s will despite having no authority to do so.
Di Natale told Guardian Australia, “It is just another example of the government with their ideological blinkers on, not only ignoring science but ignoring legislation. Even though the Senate has ruled that terminally ill patients should be able to access medicinal cannabis through Category A, the government is blackmailing the importers and threatening to remove their licenses if they supply it.”
The bill that Di Natale introduced on Tuesday, called the Medicinal Cannabis Legislation Amendment (Securing Patient Access), will prevent government from using contractual obligations of importers to stop the importation of medical marijuana for Category A use. It also clarifies the ability of patients to access drugs under Category A. Its motion of disallowance received majority Senate support, making Di Natale confident that the bill will eventually pass.
Dr. Teresa Nicoletti, an attorney and scientist with over two decades of experience in pharmaceutical law, said that it was “disgusting” that government even sent importers such a letter. Relevant customs regulations makes it very clear that if importers apply to import Category A drugs, they must receive permission, provided they supply necessary information and hold licenses to import the drug locally.
According to Nicoletti, a Mills Oakley law firm partner, “The government has basically said that ‘it does not matter what the legislation says, we will do our own thing’. It makes a mockery of the legislation. I am a strong believer in complying with legislation, and blocking access to medicinal cannabis after doing so was disallowed is in direct violation of the law.”
Because patients and doctors must apply to both the TGA and their territory or state medical regulators for medical marijuana products under Category B, patients had to apply twice and duplicate their applications, which is, frankly, a waste of time and adds an unnecessary layer of bureaucratic red tape for sick patients to deal with.
Although Nicoletti admits not knowing of any companies that are attempting to import medical marijuana to patients under Category A, she is a firm believer that importers would win if they challenged the government in court. Although some of her interest in the issue is legal, Nicoletti also admits that she has a personal stake in all this.
Nicoletti’s father died an agonizing death from cancer while she watched helplessly. Her mother has Alzheimer’s, and medical marijuana is successfully treating its symptoms. Of her father, she said, “He died in excruciating pain. I would have loved to have given him medical cannabis, as he was on as much conventional pain treatment they could supply without killing him.”
She continued to say, “I could not breach the law and try to get it for him illicitly, as that would have put my livelihood at risk. I had to watch him die in extreme pain.” Dr. Alex Wodak, president of the Law Reform Foundation, describes similar cases as simply heartbreaking. He said, “The long and short of it is that the government is presenting a mirage.”
“It looks as though the laws are OK and they are saying the right things, and yet the system is really a problem,” Wodak says. “There are clearly multiple obstacles to obtaining medical cannabis, and yet it is very difficult for ordinary people to identify them. There is clearly a smoke and mirrors operation going on. It is a complicated system that patients find unwieldy and unhelpful, and government officials get affronted when told that patients and their families find the system difficult.”
Wodak believes that illicit cannabis should become legal for recreational use and “removed as a bogeyman” to ensure medical marijuana becomes more acceptable to politicians and to society. He said, “I do not think every application for medicinal cannabis should be approved, but we need to be more flexible and have a compassionate access scheme, not just a rule-based system.”
Lanai Carter, who has been fighting for access to medical marijuana for Lindsay, her 18-year old son, has travelled with him to the United States many times to get his medicine. He has a brain tumor and intractable epilepsy, which anti-seizure drugs are unable to control, and despite Australia legalizing medical marijuana, they must still return to the U.S. and raise funds for his treatment.
“The original intention for Category A was to provide urgent fast-tracked access to medicine for chronically ill patients, but this relief for patients can only be effective if the state health departments respect the Category A process and do not require a state application over and above the Therapeutic Goods Administration,” said Queensland resident, Carter.
She went straight to the point of the matter, “This means that the whole intention of this scheme is undermined by a state application process which causes further delay.” Despite being technically unable to apply for Category A products for Lindsay, Carter said she still gets it under Category B because of the inexcusably laborious nature of the process.
However, the months it takes to get scripts approved means that even if a physician initiates a new application for the next batch of products the moment his prescription arrives, there are a few months where Carter’s son has no medicine. To complicate the issue even further, limited export options mean there is even difficulty in getting the most effective marijuana treatments exported from Australia.
According to Carter, “Lindsay can suffer up to 20 seizures per day without medical cannabis oil. Seizures put him at risk of death from sudden unexpected death, brain injury, suffocation, aspiration, and complications of aspiration, such as inhaling saliva while seizing, which can cause pneumonia, and which can cause premature death.”
“The vaporized cannabis helps him also with his pain, nausea, and it stimulates his appetite. He lost 40 kilograms since his brain tumor diagnosis, but now he has been able to regain seven kilograms and stabilize his weight. Caregivers and patients already suffering with the burdens of chronic illness should not have to be worrying about enduring bureaucratic processes and delays in access to medicine.”
Dr. David Caldicott, Australian National University’s clinical senior lecturer, said, “To say making medicinal cannabis legal has in any way made it easily accessible for the patients who need it or their clinicians would be a vast overstretch.” He is writing educational courses for Australian physicians on the history of cannabis, evidence for its use, regulatory systems, prescribing it to patients in need of it, and the possible side effects and dangers of using medical marijuana.
He claims “hundreds” of physicians are taking his courses, as medical training seldom included any information about medical marijuana, and because patients were facing significant obstacles going through the accessing process. Caldicott also said, “You must understand that there are definitely people who should not have it.”
According to him, “What we are trying to do is to establish a middle ground far removed from extremism. This is a debate that can be had entirely on medical, scientific, and intellectual merit, but people are deliberately or mistakenly confounding recreational and medicinal cannabis use.” Caldicott concluded with this statement:
“And the medical debate has been largely done and dusted overseas, where they have accepted that for some people medicinal cannabis works very well indeed, but the introduction of medicinal cannabis in Australia has become a dog’s breakfast. It has become far more of a complicated black art than it needs to be.”